1. Field of the Invention
The invention disclosed herein lies in the general field of medical instrumentation and processes. In particular, the invention relates to a method for more expeditious and expansive analysis of Holter data, i.e. a long term, ambulatory electrocardiograph (ECG). More specifically, the invention discloses a Holter analysis process, whereby Holter data accessed from an ambulatory patient in virtually any part of the earth can be submitted by a clinician via a personal computer (PC) through an Internet Service Provider (ISP) over the Internet to a centralized massive computer center where the is clinician can purchase a short term license for proprietary software and hardware to analyze the submitted data in real time and in a variety of processes and formats that might otherwise be too costly to perform. The concept of the Virtual Holter invention is a potentially generic business model for use of the Internet as a means for connecting clinicians world wide to a portal whereby the physician can acquire a short-term license to use sophisticated computer hardware and proprietary software.
2. Description of the Prior Art
The application of ECG data collected from an ambulatory or mobile patient in an uncontrolled ambulatory environment, wherein the data is further analyzed and output in a variety of reports and formats has been in practice since the early 1960""s. Known as Holter monitoring the technique is based upon the subject wearing a device that while worn collects ECG data. After a 24 to 48 hour period of continuous ECG recording, the device is removed from the patient, and the storage media (e.g. cassette tape, digital memory, etc.) is further analyzed by a trained clinician in a Holter center with a expensive Holter scanners and analyzers to create a summary document that may be accurately reviewed for diagnostic relevance by a physician or cardiologist.
The recording devices can exist at any clinical site; however, the Holter scanners and analyzers that contain proprietary software modules to summarize the collected data stream are located in clinical facilities or scanning centers that can afford the cost of the software and hardware as well as the technical staff required to operate the Holter system. The data distribution model in its most basic form assumes the collected ECG data makes its way by conventional mail or hand delivered to the site where analysis and reporting occur. The clinician who cannot justify the purchase of the expensive Holter scanners and analyzers has no alternative but to contract a facility capable of performing the analysis of Holter data and to provide a summary report. The accompanying delays in turnaround time of the report delivered by hand or by mail and the multiple parties involved in accessing the relevant reports only adds layers of unnecessary costs and loss of time, personnel intervention and accompanying opportunity for loss of data and error in reports.
A great variety of various wireless or telemetric, remote Holter monitoring devices have been conceived in the prior art that bear some distant relationship to the development of and need for the Virtual Holter invention at hand. U.S. Pat. No. 5,544,661 issued to Davis disclosed an ambulatory ECG monitoring device that tabulated and analyzed data, which data was subsequently transferred by a cell phone to a centralized monitoring and information management system for further evaluation by a clinician or primary physician. U.S. Pat. No. 5,678,562 issued to Sellers describes a similar ambulatory physiological monitor that accumulates data that can be transferred by modem and cellular telephone to a remote PC wherein the PC can in turn operate upon and control the ambulatory monitor. In still another U.S. Pat. No. 5,704,351, Mortara, yet another digital telemetry system is disclosed that transfers by telemetric means up to eight channels of ECG data. In U.S. Pat. No. 5,752,976, Duffin, a worldwide global positioning satellite, patient location and data telemetry system for implantable medical devices is disclosed. The system has the capacity to remotely locate a particular patient with an implanted medical device and can selectively monitor and operate upon a particular device world wide by telemetric means. U.S. Pat. No. 5,944,659, Flach, discloses yet another telemetric system for collection of physiological data that transmits data in real time to a centralized real time data distribution network. In U.S. Pat. No. 6,093,146, Filangeri, a pair of wireless transmission circuits are utilized in a physiological monitoring system, one for transmitting data to a centralized facility and the other acting as a communications link between the patient monitor and a base station.
It should be appreciated that applicant""s invention is not a telemetric ECG system; however, the only prior art systems that may relate to applicant""s invention by attempting to pass ECG data to a central facility for further analysis by the clinician all relate to telemetric devices. And all of the known telemetry systems have had one or more disadvantages. Telemetry systems are typically designed for use within a limited geographical area, such as a hospital or the home. In past Holter telemetry systems, the patient""s mobility is limited, and data is lost if the patient goes outside the coverage area of the system. In addition, telemetry systems transmit raw data continuously, thus requiring a dedicated transmission channel. Furthermore, prior art telemetry systems are relatively complex and expensive to operate.
Although there are numerous telemetric physiological monitoring systems for transmitting long term, ambulatory, physiological or ECG data monitors to a centralized facility for analysis or archival storage, there are no systems transmitting Holter data over a hard wired low cost medium of a local call, telephone interlink world wide, i.e. over the Internet, to a sophisticated computer facility with a wide variety of relevant software whereby one can purchase a limited license to use the centralized computer and proprietary software to perform in real time an analysis of the Holter data in a variety of differing formats and reports. There appears to be a long standing need for the implementation of a system where even very small scale clinics in any part of the world can have immediate access to very expensive computer hardware and relevant sophisticated, proprietary software to make a real time analysis of data in various formats.
The invention discloses a process for implementing and producing a Holter electrocardiograph anywhere in the world followed up by submitting the recorded data therefrom on a local phone line via a PC or independent modem over the Internet to a centralized and sophisticated Holter data analysis and processing facility where the clinician or physician at a remote facility can periodically purchase a short term license to actively use online, in real time the sophisticated computer hardware and software of the Holter center to conduct a variety of extended and detailed reports of the analysis of the long term, ambulatory ECG data from the remote clinic or medical facility. Many remote facilities around the world may not have sufficient funds and amenities to provide access to expensive, complex, elaborate and sophisticated computer hardware and software to adequately perform a thorough ECG analysis with any great degree of depth and breadth of understanding.
It is a primary object of the invention to provide an inexpensive and worldwide access (from major urban centers to remote jungle villages) to a large, sophisticated, state of the art, expensive and centralized Holter ECG data scanning, analysis and archiving hardware and software system.
It is another object of the invention to provide a worldwide, real time access to a centralized Holter scanning and analysis service.